SPOR Communications and Change Management Progress update for EUNDB & SPOR TF Presented by: Agnieszka Laka SPOR Change Team An agency of the European Union
Change management workstream The change management workstream is focusing on two key areas: 1. Communications Scope: and engagement • External stakeholders: Industry, NCAs and public 2. Training • Internal EMA stakeholders Other areas: Change Impact Assessment (CIA). This was conducted as part of the Training Needs Analysis exercise to identify key impacts resulting from RMS and OMS projects • Benefits planning and review . High level benefits identified so far. Dedicated resource is required to manage benefits planning and monitoring, so this activity is currently on hold 1
High level change management plan 2016 2017 Q1 Q2 Q3 Q4 Q1 Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Programme RMS go-live milestones RMS Key RMS UAT currently Internal OMS go-live under re-planning Release 1 OMS UAT currently go-live under re-planning Change CIA Review and Impact build out CIA Assessment Review comms & Communications & engagement - Stakeholder map/analysis approach and - Set up comms channels Develop content, approve and publish/present Engagement stakeholder - Stakeholder engagement approach analysis Build out and refine communications & - Detailed comms plan engagement plan and include UAT and - High level benefits Monitor and review communications & engagement plan training statement Training Develop training materials (RMS) materials Training Conduct Build training training TNA and training approach needs approach & analysis curriculum Training Develop training materials (OMS) materials 2 Progress to date
Establishing Change Networks We are using four mechanisms to cascade information to NCAs and to Industry and increase reach across the stakeholders 3. Stakeholder 4. SME Office 1. NCA 2. Industry Department (at EMA) Change Change (at EMA) Liaisons Liaisons To enable to contact SMEs who are not affiliated Provides a platform to promote to Industry They will form the Change Network interaction and facilitate comms between Associations Cover both domains Human and Veterinary EMA and industry 3
Cascading communications materials EMA provides centralised comms for Change Liaisons to cascade to the right people NCAs Industry • 37 NCA Change Liaisons were appointed in March 2016 • Industry Change Liaisons were appointed • Engagement plan drafted and presented at the kick-off • Engagement will begin in July (21st) through a ‘kick - webinars 11 and 12 April. Follow up webinar 26 May. off’ webinar to present the engagement plan • Key Actions from the webinars: • ‘Introduction to SPOR’ webinar is being panned in late • NCA Change Liaisons to start building their internal July for wider industry stakeholders network (progress update to EUNDB, TF) • Help to complete SPOR implementation survey • Face-to-face Change Liaison event planned for September EMA stakeholder department (established contacts at Industry Comms Associations) + Comms will be cascaded to key SME Office cascaded and stakeholders Comms published on the cascaded and within NCAs EMA web site published on and to national trade the EMA web NCAs Industry Change 37 NCA site (and associations Liaisons Change Telematics) Liaisons 4
Developing communications materials The SPOR Change Team develops communications through consultation with and feedback from key internal and external stakeholders Consultation with key stakeholders Feedback and collaboration • Consultation with Change Liaisons or other key SPOR change team encourages Change Liaisons to : representatives, when required, to identify key content and Open feedback and collaborative working to • target audiences and to develop relevant communications understand implementation progress and issues as materials they arise Sharing of knowledge, good practice and lessons • • Working with EMA Communications department to develop materials which adhere to EMA communications standards learned and to publish material on line Webinars are hosted on The SPOR Change Liaisons various topics, mailbox SPOR-Change- opportunity to ask Liaisons@ema.europa.eu questions to channel questions and EMA finalises answers between SPOR and EMA consults with EMA comms material Status reports via Change Liaisons Change Liaisons/ key drafts and shares with periodic SPOR representatives to comms implementation survey Change Liaisons SPOR update emails give identify key content material i for distribution Change Liaisons an update on SPOR implementation Data Integration SPOR Review and feedback activities and milestones microsite has been included from Change Liaisons/ under Telematics key representatives 5
SPOR Visual Identity SPOR visual identity developed with a ‘strapline’ as well as icons and colours to denote each project: SMS, PMS, OMS and RMS Example of Visual Identity Name and Strapline SPOR update poster SPOR data services – Delivering quality data services on Substances, Products, Organisations and Referentials to power EU regulatory activities Icons and Colours 6
Key engagement milestones (March – June 2016) April: NCA Change June: R&O Data Liaisons kick-off Mapping webinar webinars March: R&O roll-out plan webinar to all IT Directors May: IT Directors, HMA June: On boarding of Veterinary meeting in Rotterdam Apr - May: SPOR stakeholders prior to EUNDB / TF May: NCA Change Liaisons follow-up webinar implementation survey 7
Building an internal network at NCAs – progress update We asked NCA Change Liaisons how they are enhancing the reach of SPOR within their organisations MHRA (UK) AIFA (Italy) Norwegian Medicines State Agency of Medicines of the Republic of Latvia Agency • Business Analyst to focus on Held several internal • various matters, including meetings with the AIFA • Established two key groups: • Introduced the Change SPOR/IDMP and Telematics, and to Head of Section to share Liaison for SPOR on the actively participate in the Change the SPOR programme NoMA-intranet 1. A high level group Network roadmap, identify key focused on developing processes impacted by SPOR • Established a Steering Group the internal strategy Engaged the NCA IT • and agree action plans for for their Global Data Integration for SPOR, undertaking Director and arranged an these impacts programme which includes within changes to internal internal seminar to its remit both SPOR and Telematics processes (business introduce the internal NCA work Began a project to re- • and IT) as a result of audience to SPOR engineer AIFA IT SPOR and delegating • Secured cross-Agency architecture to simplify the tasks related to these representation from senior Planned preliminary work • interoperability with EMA managers for the Steering Group, on processes and systems shared services (i.e., OMS, which provides excellent 2. Another group focused impacted by SPOR RMS, etc) engagement across all operational on data mapping and units at the MHRA providing support to Established a small group • the high level group. • Presented and gained MHRA of people to focus on data Executive Team support for a mapping programme proposal • Established internal meetings incorporating Telematics and to identify what else is needed for SPOR (and other programmes). SPOR MHRA is now mobilising resources and establishing programme governance 8
SPOR implementation questionnaire Response Statistics • Questionnaires (H, H/V and V NCAs) circulated 26 April & 10 May 2016 • To enable the Network to track progress of implementation of SPOR • Analysis conducted in preparation for HMA Rotterdam meeting. Responses continued to come in after the deadlines, they were included prior to HMA until 23/24 May • Human NCAs and Human/Vet NCAs: 21 out of 30 responses analysed; 9 discounted • Vet-only NCAs: 4 out of 8 responses analysed; 4 discounted • Responses have been discounted for two reasons: Responses are incomplete or the questionnaire has been answered by the wrong audience e.g. Vet-only responding to Human/Vet questionnaire 9
SPOR implementation questionnaire – Summary of Human and Human/Vet responses: Awareness 1 2 SPOR projects’ background and Benefits to your organisation of the purpose? implementation of SPOR? 45.0% 40.0% >= 60% sufficient 40.0% 35.0% or good awareness 35.0% 30.0% 30.0% of SPOR context, 25.0% 25.0% benefits and 20.0% 20.0% among leadership 15.0% 15.0% 10.0% 10.0% 5.0% 5.0% 0.0% 0.0% More work needed None Low Sufficient Good None Low Sufficient Good to improve general 3 4 Support for SPOR among senior awareness leadership within your organisation? OMS and RMS operating models? 50.0% 60.0% 45.0% 50.0% 40.0% 35.0% 40.0% 30.0% Clear need to 25.0% 30.0% address 20.0% 20.0% 15.0% understanding of 10.0% 10.0% operating models 5.0% 0.0% 0.0% None Low Sufficient Good None Low Sufficient Good 10
Recommend
More recommend
